We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Evaluation of Cow Milk-Based Formulas - Functional Proteins

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00916565
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : September 2, 2011
Information provided by:
Mead Johnson Nutrition

Brief Summary:
The purpose of this study is to look at the function of infant formula components to optimize the nutritional content and functionality of a marketed routine infant formula.

Condition or disease

Study Type : Observational
Estimated Enrollment : 139 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Evaluation of Cow Milk-Based Formulas - Functional Proteins
Study Start Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Experimental milk-based infant formula
Control milk-based infant formula
Breastfed Reference Group

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 18 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
formula-fed and breastfed infants

Inclusion Criteria:

  • 10-18 days of age
  • 37-42 weeks gestation
  • birth weight 2500 g or more
  • consuming one source of nutrition

Exclusion Criteria:

  • metabolic or chronic disease
  • acute infection
  • feeding difficulties
  • consumed complementary foods or donor milk
  • steroid use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916565

United States, Alabama
Dr. Claude Ashley
Birmingham, Alabama, United States, 35235
William Johnston, MD
Birmingham, Alabama, United States, 35235
United States, Arkansas
Lori Montgomery, MD
Little Rock, Arkansas, United States, 72205
United States, Florida
Edward Zissman, MD
Lake Mary, Florida, United States, 32746
Harold Deulofeut MD
Plantation, Florida, United States, 33324
Harold Deulofeut MD
Tamarac, Florida, United States, 33321
United States, Kansas
Susan Carlson, Ph.D.
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Joseph Leader, MD
Woburn, Massachusetts, United States, 01801
United States, Nebraska
Ann Grandjean, Ed. D
Omaha, Nebraska, United States, 68105
United States, Tennessee
Laurie Harris-Ford, MD
Clarksville, Tennessee, United States, 37043
United States, Texas
Beth Nauert, MD
Austin, Texas, United States, 78745
Sponsors and Collaborators
Mead Johnson Nutrition

Responsible Party: Bryan Liu, Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT00916565     History of Changes
Other Study ID Numbers: 3378-3
First Posted: June 9, 2009    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: August 2011

Keywords provided by Mead Johnson Nutrition:
optimize nutritional content of infant formula